FDA removes clinical hold on Immuron's new campylobacter ETEC therapeutic

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Immuron (ASX:IMC) has announced that the US Naval Medical Research Center has received approval from the US FDA to proceed with the clinical evaluation of the new oral therapeutic targeting campylobacter and enterotoxigenic Escherichia coli (ETEC).

Immuron is an Australian-based company that has developed two commercially available oral immunotherapeutic products for the treatment of gut-mediated diseases.

The clinical evaluation will now proceed to evaluate the efficacy of the hyperimmune product to prevent infectious diarrhoea caused by Campylobacter and ETEC.

Immuron said the safety and protective efficacy of the product will be tested utilising two controlled human infection model clinical trials, with one focusing on the ability of the product to protect volunteers against ETEC infections and the second focusing on moderate to severe campylobacteriosis.

A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the randomised, placebo-controlled trials and randomly assigned to either Cohort 1 ETEC or Cohort 2 C. The study population will include 30 healthy participants aged 18- 50 years.